These devices are intended to be used as replacement door assemblies for Baxter Flo-Gard 6201 and Baxter Flo-Gard® 6301 volumetric infusion pumps, for use to deliver drug solutions, enteral feedings and blood.

Device Description

AIV's pump door assemblies are replacements for similar doors manufactured by Baxter Healthcare Corporation for their Flo-Gard® 6201 and Flo-Gard® 6301 Volumetric Infusion Pumps. The door is part of a linear peristaltic pumping mechanism. The door assemblies are intended to be direct replacement for the predicate device door assembly.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the AIV Replacement Pump Head Door Assembly:

Acceptance Criteria and Device Performance

The core acceptance criterion for the AIV Replacement Pump Head Door Assembly is its performance in terms of flow volume accuracy.

Acceptance Criteria	Reported Device Performance
Flow volume within 7% of programmed volume for a programmed flow rate	"Bench Testing demonstrates that the AIV devices perform as intended and are equivalent to predicate device assemblies." (Implicitly, this means they meet the 7% tolerance, as the predicate device has the same performance criteria.)

Study Information

The provided document describes a bench testing study, but lacks detailed numerical results beyond the general statement of equivalence.

Sample size for the test set and data provenance:
- Sample Size: Not explicitly stated. The document refers to "Bench Testing" and "AIV devices," but does not provide the number of units tested.
- Data Provenance: Not explicitly stated, but can be inferred as retrospective as it's a comparison to established predicate devices. The study was conducted by the manufacturer, American IV Products, Inc. (AIV). The country of origin of the data is likely USA, as the submitting company is based in Maryland.
Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable. This was a bench test comparing the functional performance of the AIV device to its predicate. Ground truth in this context would likely be established by validated test equipment and calibration standards, not expert human assessment.
Adjudication method for the test set:
- Not applicable for this type of bench testing. Performance would be objectively measured using calibrated instruments against a defined specification.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
- No, an MRMC comparative effectiveness study was not conducted. This device is a component of an infusion pump, and its performance is assessed via engineering bench tests, not human interpretation of medical cases.
Standalone (algorithm-only) performance:
- Yes, a standalone performance evaluation was done in the sense that the AIV device was tested on its own (or in place of the predicate device component) to verify its functional performance. This is an engineering test, not an algorithm-only test in the context of AI/ML.
Type of ground truth used:
- The ground truth for this study is the established performance specifications of the predicate device (Baxter Flo-Gard 6201 and 6301) and general engineering standards for flow rate accuracy. This is based on objective, quantifiable measurements.
Sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. The "design" and "materials" were presumably developed through engineering processes, prototyping, and testing, but not in the sense of a dataset for machine learning.
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the AI/ML sense. The "ground truth" for the design of the AIV device was the existing, legally marketed predicate devices and their known performance characteristics.

Summary

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K032789

OCT = 9 2003

Image /page/0/Picture/2 description: The image shows the logo for AIV, which is a company that supports clinical engineering worldwide. The logo is black and white and features a star above the letters AIV. The text "Supporting Clinical Engineering Worldwide" is below the logo.

Appendix C Page 1 of 2

510(k) Summary

Submitter Information:

American IV Products, Inc. 7485 Shipley Avenue Hanover, MD 21076

Contact:

Gregory Falk Engineering Manager Telephone: 410-787-1300 ext. 131 Fax:: 410-787-1337 e-mail: gfalk@aiv-inc.com

Date Prepared:

August 22, 2003

Product Name:

Classification Name: Volumetric Infusion Pump Door Assembly Common Name: Replacement Pump Head Door Assembly, P1 Replacement Pump Head Door Assembly, P2 Proprietary Name: Replacement Pump Head Door Assembly, P1 Replacement Pump Head Door Assembly, P2

Predicate Device:

These door assemblies are equivalent to the legally marketed door assemblies in the following devices:

Baxter Flo-Gard® 6201 - K915522 Baxter Flo-Gard® 6301 – K915523

Description:

Intended Use:

These devices are intended to be used as replacement door assemblies for Baxter Flo-Gard® 6201 and Baxter Flo-Gard® 6301 volumetric infusion pumps, for use to deliver drug solutions, enteral feedings and blood.

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Comparison to Predicate Device:

	AIV	Baxter
Intended use	Pump head door assembly for use in a volumetricinfusion pump that uses a linear peristaltic pumpingmechanism.	Same
Design	A latching plastic and metal door that contains aspring mounted pump backing plate	Same
Materials	Molded plastic door "blank" that contains aluminumand brass inserts, an aluminum back plate, springloaded nylon constructed pump backing plate, plasticlatch handle with stainless steel pin, bronze latchbushing, and rubber bumpers.	Same
Performance	Flow volume within 7% of programmed volume for aprogram flow rate	Same
Where used	Hospital	Same
Biocompatibility	Not intended for contact with patient skin or contactwith operator/programmer skin for prolonged periodsof time.	Same
Sterility	Non-sterile	Same

Performance Data and Conclusions:

AIV door assembly components are made from similar materials to the predicate device . component materials.
. AIV component design is equivalent to predicate device component design.
. AIV assembly design is equivalent to predicate device assembly design.
Bench Testing demonstrates that the AIV devices perform as intended and are equivalent . to predicate device assemblies.
. Bench testing demonstrates that the AIV door "blank" component of a door assembly when used in place of a predicate device door "blank" component in an otherwise complete predicate device door assembly, the hybrid assembly performs as intended and is equivalent to predicate device door assembly.
. These devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 2003

Mr. Gregory Falk Engineering Manager American IV Products, Incorporated 7485 Shipley Avenue Hanover, Maryland 21076

Re: K032789

Trade/Device Name: Replacement Pump Head Door Assembly, P1, and P2 Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: August 22, 2003 Received: September 8, 2003

Dear Mr. Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix B Page 1 of 1

Statement of Indications for Use

510(k) # 232789

Device Name: Replacement Pump Head Door Assembly, P1 Replacement Pump Head Door Assembly, P2

Indications for use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cuccuriti

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K032789

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).